68Ga-PFA2 PET Imaging for the Diagnosis of Annexin A2-Positive Tumors

January 15, 2026 updated by: Tingting Yuan, Peking University First Hospital

PET Imaging Study of 68Ga-PFA2 Probe for Annexin A2-Positive Tumors

Tumor metastasis and invasion are the leading causes of cancer-related deaths, with over 90% of cancer patients dying from distant metastasis. Tumor cells spread to distant organs through local infiltration, hematogenous metastasis, or lymph node metastasis, complicating treatment and severely affecting the prognosis and survival rate of patients. Therefore, precise and early assessment of tumor invasion and metastasis is crucial for optimizing personalized treatment plans and improving patient survival.

Currently, the detection of tumor metastasis primarily relies on imaging examinations, blood biomarkers, and histopathological analysis. Among these, 18F-FDG PET/CT plays a key role in tumor staging and distant metastasis evaluation. However, its sensitivity is low for certain tumors, such as well-differentiated hepatocellular carcinoma, colorectal cancer, and glioblastoma, and factors like inflammation can lead to false positives. Additionally, serum tumor markers (such as AFP, CEA, and CA19-9) often lack specificity in some patients, and histopathological analysis requires invasive sampling, making real-time monitoring difficult. Therefore, the development of non-invasive methods based on molecular targets for early and precise detection of tumor invasion and metastasis holds significant clinical value.

Tumor invasion and metastasis is a complex process involving multiple molecules that drive cancer cell proliferation, invasion of surrounding tissues, and the formation of secondary tumors in distant organs. During invasion and metastasis, cancer cells are often subjected to mechanical stress, such as compression and shear forces, making the repair of cell membrane damage crucial for the survival of invasive cancer cells. Annexin A2 (ANXA2) is a multifunctional protein that plays a key role in cancer cell membrane repair, proliferation, migration, invasion, and metastasis. Studies have shown that silencing ANXA2 or inhibiting its function with neutralizing antibodies reduces the ability of cancer cells to repair membrane damage, thereby limiting tumor cell dissemination. Abnormal expression of ANXA2 is a common feature in many types of tumors. The expression level of ANXA2 in tumors is closely associated with the growth, invasion, and metastasis of pancreatic cancer, colorectal cancer, breast cancer, gliomas, and other tumors.

Furthermore, ANXA2 promotes tumor cell proliferation by facilitating DNA replication, cell cycle progression, and neovascularization, thereby supporting tumor growth and progression. For instance, in breast cancer, ANXA2 promotes STAT3 activation through Tyr23 phosphorylation, upregulating cyclin D1 and MMP2/9, which accelerates breast cancer proliferation, invasion, and metastasis. In pancreatic cancer, ANXA2 regulates the Src/ANXA2/STAT3 signaling pathway to promote epithelial-mesenchymal transition (EMT), enhancing cellular invasiveness. In non-small cell lung cancer (NSCLC), ANXA2 overexpression correlates with tumor staging, lymph node metastasis, and distant metastasis, and can serve as an independent prognostic marker. In hepatocellular carcinoma (HCC), high ANXA2 expression is not only associated with higher tumor recurrence rates but also promotes angiogenesis, further driving tumor progression. In glioblastoma (GBM) and colorectal cancer, ANXA2 has also been shown to accelerate disease progression through mechanisms such as extracellular matrix degradation, angiogenesis, and tumor microenvironment regulation.

ANXA2 not only serves as a poor prognostic factor for various cancers but also holds potential as a therapeutic target. Several monoclonal antibodies targeting ANXA2 have shown significant antitumor and antiangiogenic effects. Rajkumar et al. demonstrated that the monoclonal antibody mAb150, targeting the N-terminal epitope of ANXA2, enhances cancer stem cells' re-entry into the cell cycle, reducing migration and EMT in activated cancer cells, ultimately inhibiting ascites formation and extending survival in a mouse ovarian cancer model. Another monoclonal antibody, ch2448, targets the unique glycan epitope of ANXA2, triggering antibody-dependent cell-mediated cytotoxicity, effectively inhibiting tumor formation and delaying or preventing teratoma development. In addition to large molecular antibodies, the first small-molecule inhibitor of ANXA2 in triple-negative breast cancer, 5α-epoxyalantolactone (5-EAL), has been discovered. 5-EAL selectively binds to the conserved cysteine residue of ANXA2, inhibiting the formation of the ANXA2-S100A10 heterotetramer complex, effectively suppressing TNBC proliferation and metastasis. These findings highlight the enormous diagnostic and therapeutic potential of ANXA2 as a biomarker for malignant cancers.

Given the high expression of ANXA2 in various tumors and

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

10

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China
        • Recruiting
        • Peking university first hospital nuclear medicine
        • Contact:
        • Contact:
          • Tingting Yuan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

This study will include lung cancer patients, both suspected and confirmed, who are scheduled to undergo PET/CT imaging using the 68Ga-PFA2 probe. The study will focus on patients aged 18-80 years with confirmed lung cancer, and the participants should be able to understand the study protocol, provide informed consent, and cooperate with examination procedures.

Description

Inclusion Criteria:

  • Patients aged 18-80 years.
  • Diagnosed with confirmed lung cancer.
  • Scheduled to undergo pathological tissue biopsy or surgical treatment within the next two months.
  • Able to fully comprehend and voluntarily participate in the study.
  • Able to provide informed consent.
  • Capable of cooperating independently to complete the examinations.

Exclusion Criteria:

  • Patients with other malignancies or severe comorbidities that affect their ability to participate.
  • Patients unable to provide informed consent due to cognitive impairment.
  • Patients with contraindications to PET/CT scans or 68Ga-PFA2 administration.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Lung cancer patients will undergo PET/CT imaging with 68Ga-PFA2 to assess metastasis detection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnostic Performance of 68Ga-PFA2 PET Imaging in Detecting Metastasis in Lung Cancer
Time Frame: Primary data collection will be completed at the end of the study, with imaging performed at baseline and 30-minute, 60-minute intervals post-injection.
Primary data collection will be completed at the end of the study, with imaging performed at baseline and 30-minute, 60-minute intervals post-injection.
Diagnostic Performance of 68Ga-PFA2 PET Imaging in Detecting Metastasis in Lung Cancer
Time Frame: Primary data collection will be completed at the end of the study, with imaging performed at baseline and 30-minute, 60-minute intervals post-injection.
This outcome measure evaluates the ability of the 68Ga-PFA2 PET imaging probe to detect metastases in lung cancer patients, focusing on Annexin A2-positive tumors. The primary objective is to assess its diagnostic performance compared to the standard 18F-FDG PET/CT imaging.
Primary data collection will be completed at the end of the study, with imaging performed at baseline and 30-minute, 60-minute intervals post-injection.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University First Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2025

Primary Completion (Estimated)

October 1, 2027

Study Completion (Estimated)

October 1, 2027

Study Registration Dates

First Submitted

December 29, 2025

First Submitted That Met QC Criteria

December 29, 2025

First Posted (Estimated)

January 12, 2026

Study Record Updates

Last Update Posted (Actual)

January 20, 2026

Last Update Submitted That Met QC Criteria

January 15, 2026

Last Verified

December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PFA2 001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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